- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01181089
Dose Escalation Study to Evaluate the Penetration and Pharmacodynamic Effects of Baminercept in the Cerebrospinal Fluid (CSF)and Safety in Subjects With Secondary Progressive Multiple Sclerosis (SPMS)
September 12, 2013 updated by: Biogen
A Multicenter, Randomized, Blinded, Placebo-Controlled, Dose Escalation Study to Evaluate the Penetration and Pharmacodynamic Effects of Baminercept in the Cerebrospinal Fluid (CSF) and Safety in Subjects With Secondary Progressive Multiple Sclerosis
This is a prospective, randomized, multicenter, dose escalation study to determine subject safety, pharmacokinetic, and pharmacodynamic responses in patients with SPMS
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
Detailed Description
This study is a prospective, randomized, placebo-controlled, blinded, dose escalation study of 3 to 4 cohorts with defined number of patients per cohort receiving active drug or placebo for a period of 4 months followed by safety monitoring for an additional 4 months after the last dose
Study Type
Interventional
Phase
- Phase 2
- Phase 1
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 57 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- A diagnosis of Secondary Progressive Multiple Sclerosis
- Aged 18 to 57 years old, at the time of informed consent
Exclusion Criteria:
- History of clinically important (as determined by the investigator) cardiac, endocrinologic, pulmonary, neurologic, immune, psychiatric, hepatic, renal or hematologic insufficiency or any other major disease other than MS ( Multiple Sclerosis)
- Inability in the opinion of the Investigator to comply with study requirements
- Other protocol-defined criteria may apply
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Triple
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Measure: Change in cerebrospinal fluid levels of secondary lymphoid organs chemokines from baseline with baminercept relative to placebo
Time Frame: after 4 months of treatment
|
after 4 months of treatment
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of subjects experiencing Serious Adverse Event (SAE) and Adverse Event (AE) with baminercept relative to placebo
Time Frame: 8 months (4 months on drug, 4 months post-drug)
|
8 months (4 months on drug, 4 months post-drug)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2010
Study Registration Dates
First Submitted
August 5, 2010
First Submitted That Met QC Criteria
August 12, 2010
First Posted (Estimate)
August 13, 2010
Study Record Updates
Last Update Posted (Estimate)
September 16, 2013
Last Update Submitted That Met QC Criteria
September 12, 2013
Last Verified
January 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Nervous System Diseases
- Immune System Diseases
- Neoplasms
- Demyelinating Autoimmune Diseases, CNS
- Autoimmune Diseases of the Nervous System
- Demyelinating Diseases
- Autoimmune Diseases
- Neoplastic Processes
- Multiple Sclerosis
- Multiple Sclerosis, Chronic Progressive
- Sclerosis
- Neoplasm Metastasis
Other Study ID Numbers
- 104MS101
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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